Clinical FSP Business

IQVIA clinical FSP business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our clients. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.

Leadership recognizes the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.

Unique to the FSP model, our team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’. Additionally, IQVIA’s FSP business works with the Sponsors SOP’s, creating more continuity for both parties.

Our models offer excellent opportunities for experienced CRA’s to expand their knowledge and skills.

Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, quality /compliance and performance standards. Assigned responsibilities can include but are not limited to:

• Development of specific sections of the protocol and related documents
• Development of study tools, guidelines and training materials
• Organization and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee)
• Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries)
• Supporting forecast and management of drug supply for sponsor and comparator drug products in collaboration with internal stakeholders
• Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts
• Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer and clinical development representative
• Implementing issue resolution plans
• Acting as point of contact for all site-related issues and procedural questions
• Managing interactions with relevant line functions including data management, drug supply management, clinical development and Sponsor Country Pharma Organizations
• Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation
• Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes
• Organize and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT)
• As member of the CTT, contribute to defining the Data Review Plan; participate in data review as specified in the Data Review Plan
• May contribute to talent development through active participation in onboarding and training activities. May participate in GDO Trial Management initiatives and working groups
• Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise, including sharing lessons learned.

Resource Management:

• Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget including forecast and annual cost targets

Key Performance Indicators:

• Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards
• Proactive operational planning with effective contingency and risk mitigation plans

Ideal Background:

• Typically requires a minimum of 7 - 10 years of clinical research experience
• At least 2 years of clinical project management (as Global Trial Manager, Clinical Lead, Project Lead or similar
• Excellent communication, organization and tracking skills
• Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines
• Proven networking skills and ability to share knowledge and experience amongst colleagues
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process
• Basic knowledge of appropriate therapeutic area
• Fluent English (oral and written)
• Full time and Home-based position

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.